Lutronic Healite II

The Lutronic Healite II is a light emitting diode system, not a laser. FDA cleared it in June 2012 under K113668, with the Omnilux Plus as predicate. The 510(k) summary describes an LED source of high spectral purity at 830 nm in the near infrared, a 590 nm aiming beam, a base unit holding the power supply and control system, and user interface software that runs all device functions. Lutronic submitted it under the powered surgical laser classification while noting that it is not a laser, and FDA's clearance letter placed it under the infrared lamp regulation, product code ILY.

The US clearance covers temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relief of stiffness, relaxation of muscle tissue, and a temporary increase in local blood circulation where the light is applied. The summary says the system is packaged with an LED head for the particular intended use, so the head defines what a given unit is set up to do. No clinical performance data were presented in the submission.

FDA's device identifier database lists the Healite main body assembly as a separate part, published in 2016, and a 2026 record for a US configuration named HEALITE II (830nm) for 110 volt power. Because the wavelength is written into that model name, it is the first detail to check on your own label. If your head or label shows a wavelength other than 830 nm, say so in the listing, since the US clearance describes only the 830 nm source.

When you list a Healite II, give the model label exactly as printed, the wavelength marked on each head, and the voltage rating. Buyers will ask whether every LED in the head lights, whether the head holds its position, and whether the screen and controls respond. Add the service history, any error messages, and photos of the label, the head and the main screen so a dealer can confirm the configuration before making an offer.